Frequently Asked Questions
Are the cases FDA-registered?
Our cases are not FDA-registered as medical devices, but the materials are FDA-compliant for indirect food contact and medical device transport. We provide material certificates and compliance documentation on request.
Can the case hold cold chain items (2-8°C)?
Yes. We offer insulated cases with PCM (Phase Change Material) cooling panels maintaining 2-8°C for 24-72 hours. For frozen transport (-20°C), we use dry ice compartments with CO2 venting. We can integrate temperature data loggers (Sensitech, Elpro, LogTag) with USB/Bluetooth/LoRa output.
Are the cases validated per WHO PQS standards?
Yes. Our pharma transport cases meet WHO PQS E001 for vaccine transport. We provide IQ/OQ/PQ documentation, thermal mapping studies, and 3-shipment qualification protocols. Lead time for full validation: 4-6 weeks.
What foam is used for medical cases?
Closed-cell polyethylene (PE) foam, autoclavable to 134°C, non-reactive with most drug formulations. Anti-static coating available. Optional: high-density foam for heavy medical devices, low-density foam for consumables.
Can the case include 95kPa pressure-tested secondary packaging?
Yes. We supply 95kPa pressure-tested secondary containers (UN3373 Biological Substance Category B compliant). Foam secures the primary sample tubes inside the pressure-tested secondary pouch. Tested per IATA DGR and ICAO regulations.
Is the foam compatible with disinfectant cleaning?
Yes. Foam withstands common disinfectants: isopropyl alcohol (70%), bleach (1:10 dilution), hydrogen peroxide (3%), quaternary ammonium compounds, and peracetic acid. Avoid strong solvents (acetone, MEK) which can damage the foam.
Can the case be sterilized?
Yes. We support EtO (ethylene oxide) gas sterilization, gamma irradiation (up to 50kGy), and autoclave cycles (121°C standard, 134°C for foam). For sterile-field use, we ship double-bagged in Tyvek pouches.
What about cases for diagnostic sample transport?
Yes. We custom-foam cases for blood collection tubes (Vacutainer, Monovette, Greiner), urine cups, swab kits, PCR plates, and rapid test cassettes. Foam holds tubes upright to prevent leakage during transport.
Do you have cases for medical devices like ultrasound?
Yes. We have layouts for portable ultrasound (GE Vscan, Philips Lumify, Butterfly iQ, Clarius), patient monitors (Philips IntelliVue, GE CARESCAPE), defibrillators, infusion pumps, and ventilators. Foam protects against 5G shock during ambulance transport.
Are the cases used by EMS and ambulance services?
Yes. Our EMS cases (430x330x180mm to 630x480x300mm) are deployed in ambulances, helicopters (HEMS), and motorcycle response units worldwide. Foam is customized for ALS and BLS kits with compartments for bags, monitors, drugs, and airway equipment.
Do you have cases for clinical trials and IP transport?
Yes. We supply cases for investigational product (IP) transport to clinical trial sites. Foam includes patient kit organization, dosing schedule cards, and tamper-evident seals. We support 5-50 site studies with consolidated shipment tracking.
What is the warranty?
5 years on case shell, 2 years on hardware, 1 year on foam. Lifetime technical support. For pharma clients, we offer extended warranty (7-10 years) and dedicated RMA service with 48-hour replacement.
